AzTrials
AzTrials

Metastatic DiseaseMAMETICNCT04595032

MAnagement of METastatic Disease in Campania (MAMETIC)

An observational study of Metastatic Disease, run by National Cancer Institute, Naples at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The MAMETIC Trial represents the first regional epidemiological study that aims to evaluate patients living in Campania with metastatic cancer, with the intent to detect different prevalence of tumors in the metastatic phase and evaluate the local response to the patient's request for assistance. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Disease
What is being tested?
3DCRT, IMRT, VMAT, SBRT
Type of treatment
Medical device
How many people
3,234 participants
Where
1 siteItaly
Study dates
11 Sep 2020to 8 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with metastatic disease candidates for radiotherapy and resident in Campania region

Who may be able to join

  • Patients aged > 18 years resident in Campania Region;
  • Patients diagnosed with metastatic disease candidates for radiotherapy
  • Metastatic patients candidates for radiotherapy re-treatment
  • Oligometastatic patients candidates for radiotherapy; Patients who have given their consent

Who cannot join

  • Patients aged < 18 years
  • Patients who are unable to express consent to sensitive data and radiant treatment

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Radioterapia Oncologica INT IRCCS- Fondazione G.Pascale Sede Centrale

    Naples, Campania

Other trials in Italy

About this study

Official title: MAnagement of METastatic Disease in Campania (MAMETIC): Role of Radiotherapy in an Italian Region: Protocol for an Observational Multicenter Trial

The MAMETIC Trial represents the first regional epidemiological study that aims to evaluate patients living in Campania with metastatic cancer, with the intent to detect different prevalence of tumors in the metastatic phase and evaluate the local response to the patient's request for assistance.

Condition or disease: Metastatic disease Intervention/treatment: Radiation Treatment

Read the detailed description

The MAMETIC Trial is a multicenter, retrospective and prospective observational study and 17 of 20 RT Centers in Campania joined it.

  1. The retrospective part of the study concerns all patients enrolled with a diagnosis of metastatic disease and treated in RT centers of the Campania Region with 3DCRT, IMRT, VMAT, SBRT techniques from January 2019 to August 2020. In 2019, it has been enrolled 12.500 patients in the 17 RT Centers and it is estimated that 20-30% of the above mentioned patients had metastasis. Thus, approximately 2.560 patients are expected to be enrolled.
  2. The prospective part of the study is going to enroll all metastatic patients eligible for palliative RT, treated in RT Centers of the Campania region with 3DCRT, IMRT, VMAT, SBRT techniques from September 2020 to September 2025. Considering the RT Centers that joined the trial, it is expected to enroll approximately 2.500-4.200 patients per year and a total of 12.500-21.000 patients in 5 years.

The study will last 61 months, divided as follow: 60 months of enrollment phase and up to 1 month of follow-up for pain and bone metastasis patients. Follow-up will be performed on the 15th and 30th day after the end of radiation treatment.

Being tested
3DCRT, IMRT, VMAT, SBRT
Keywords
Palliative care, Metastatic disease, Radiotherapy, Cancer pain, Breakthrough Cancer Pain, Quality of Life
Medical subject headings
Neoplasm Metastasis, Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3DCRT, IMRT, VMAT, SBRTDevice

    Radiation treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retrospective Study: Occurrence of palliative radiotherapy treatments in the Campania region

    Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological Study)

    Measured: 20 months (Interval from January 2019 to August 2020)

  2. Prospective Study: Occurrence of palliative radiotherapy treatments in the Campania region

    Occurrence of palliative radiotherapy treatments in the Campania region (Epidemiological study)

    Measured: 60 months (Interval from September 2020 to September 2025)

Secondary outcomes (12)

  1. Retrospective Study: a. Incidence of metastatic disease at diagnosis

    Incidence of metastatic disease at diagnosis

    Measured: 20 months (Interval from January 2019 to August 2020)

  2. Retrospective Study: b. Time between first diagnosis and the onset of metastases

    Time between first diagnosis and the onset of metastases

    Measured: 20 months (Interval from January 2019 to August 2020)

  3. Prospective Study: Level A a. Incidence of metastatic disease at diagnosis

    Incidence of metastatic disease at diagnosis

    Measured: 60 months (Interval from September 2020 to September 2025)

  4. Prospective Study: Level A b. Time between first diagnosis and the onset of metastases

    Time between first diagnosis and the onset of metastases

    Measured: 60 months (Interval from September 2020 to September 2025)

  5. Prospective Study: Level A c. Interval from the first course of the radiation therapy to the retreatment

    Interval from the first course of the radiation therapy to the retreatment (Epidemiological study)

    Measured: 60 months (Interval from September 2020 to September 2025)

  6. Prospective Study: Level B a. Pain control

    Pain control measured for patient self-reporting of pain with Numeric Rating Scale (NRS) score, a 11-point scale (from 0 to 10), with higher scores indicating greater pain intensity

    Measured: Up to 1 month after the end of RT

  7. Prospective Study: Level C a. Quality of Life (QoL) according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire (health-related quality of life).

    Quality of life (QoL) according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire (health-related quality of life). It is scored on a metric from 0 to 10, higher scores mean better outcome

    Measured: Until 2 weeks before RT

  8. Prospective Study: Level C b. Functional performance measured by Palliative Performance Score (PPS).

    Functional performance measured by Palliative Performance Score (PPS). To score, there are 11 levels of PPS from 0% to 100% in 10 percent increments. Every decrease in 10% marks a fairly significant decrease in physical function.

    Measured: Until 2 weeks before RT

  9. Prospective Study: Level C c. Quality of life (QoL) of patients with bone metastases according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 questionnaire (health-related quality of life).

    Quality of life (QoL) of patients with bone metastases according to European Organization for Research and Treatment of Cancer (EORTC) QLQ-BM22 questionnaire (health-related quality of life). It is scored on a metric from 0 to 100. Higher scores mean better outcome.

    Measured: Until 2 weeks before RT

  10. Prospective study: LEVEL C d. Incidence of spinal instability in patients with spinal metastases according to Spinal Instability Neoplastic Score (SINS)

    Incidence of spinal instability in patients with spinal metastases according to Spinal Instability Neoplastic Score (SINS). It is scored from 0 to 18. Higher scores mean worse outcome.

    Measured: Until 2 weeks before RT

  11. Prospective study: LEVEL C e. Evaluation of functional impairment as a result of their spinal cord injury according to the American Spinal Injury Association (ASIA) Score.

    Evaluation of functional impairment as a result of their spinal cord injury according to the American Spinal Injury Association (ASIA) Score. It is scored from 0 to 324. Higher scores mean better outcome.

    Measured: Until 2 weeks before RT

  12. Prospective study: LEVEL C f. Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination.

    Assessment of cognitive function in patients with brain metastases by Mini-Mental State Examination. It is scored from 0 to 30. Higher scores mean better outcome.

    Measured: Until 2 weeks before RT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start11 Sep 2020
  3. Primary completion8 Feb 2024
  4. Study completion8 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
3,234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595032
Sponsor's protocol ID
33/20 oss
Acronym
MAMETIC
Status last verified
Jun 2024
First submitted
7 Sep 2020
Last updated
7 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bogenrieder T, Herlyn M. Axis of evil: molecular mechanisms of cancer metastasis. Oncogene. 2003 Sep 29;22(42):6524-36. doi: 10.1038/sj.onc.1206757.

    PubMed 14528277

  • Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000 Jan 7;100(1):57-70. doi: 10.1016/s0092-8674(00)81683-9. No abstract available.

    PubMed 10647931

  • Dillekas H, Demicheli R, Ardoino I, Jensen SAH, Biganzoli E, Straume O. The recurrence pattern following delayed breast reconstruction after mastectomy for breast cancer suggests a systemic effect of surgery on occult dormant micrometastases. Breast Cancer Res Treat. 2016 Jul;158(1):169-178. doi: 10.1007/s10549-016-3857-1. Epub 2016 Jun 15.

    PubMed 27306422

  • Gupta GP, Massague J. Cancer metastasis: building a framework. Cell. 2006 Nov 17;127(4):679-95. doi: 10.1016/j.cell.2006.11.001.

    PubMed 17110329

  • Dillekas H, Rogers MS, Straume O. Are 90% of deaths from cancer caused by metastases? Cancer Med. 2019 Sep;8(12):5574-5576. doi: 10.1002/cam4.2474. Epub 2019 Aug 8.

    PubMed 31397113

  • Huang JF, Shen J, Li X, Rengan R, Silvestris N, Wang M, Derosa L, Zheng X, Belli A, Zhang XL, Li YM, Wu A. Incidence of patients with bone metastases at diagnosis of solid tumors in adults: a large population-based study. Ann Transl Med. 2020 Apr;8(7):482. doi: 10.21037/atm.2020.03.55.

    PubMed 32395526

  • 7. AIOM-AIRTUM . Il numero del cancro in Italia 2019 . Intermedia Editore

  • Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s. doi: 10.1158/1078-0432.CCR-06-0931.

    PubMed 17062708

  • Koswig S, Budach V. [Remineralization and pain relief in bone metastases after after different radiotherapy fractions (10 times 3 Gy vs. 1 time 8 Gy). A prospective study]. Strahlenther Onkol. 1999 Oct;175(10):500-8. doi: 10.1007/s000660050061. German.

    PubMed 10554645

  • Townsend PW, Smalley SR, Cozad SC, Rosenthal HG, Hassanein RE. Role of postoperative radiation therapy after stabilization of fractures caused by metastatic disease. Int J Radiat Oncol Biol Phys. 1995 Jan 1;31(1):43-9. doi: 10.1016/0360-3016(94)E0310-G.

    PubMed 7995767

  • Mirels H. Metastatic disease in long bones. A proposed scoring system for diagnosing impending pathologic fractures. Clin Orthop Relat Res. 1989 Dec;(249):256-64.

    PubMed 2684463

  • Chow E, Zeng L, Salvo N, Dennis K, Tsao M, Lutz S. Update on the systematic review of palliative radiotherapy trials for bone metastases. Clin Oncol (R Coll Radiol). 2012 Mar;24(2):112-24. doi: 10.1016/j.clon.2011.11.004. Epub 2011 Nov 29.

    PubMed 22130630

  • Sze WM, Shelley M, Held I, Mason M. Palliation of metastatic bone pain: single fraction versus multifraction radiotherapy - a systematic review of the randomised trials. Cochrane Database Syst Rev. 2004;2002(2):CD004721. doi: 10.1002/14651858.CD004721.

    PubMed 15106258

  • Di Franco R, Falivene S, Ravo V, Mammucari M, Sarli E, Baffini S, De Palma G, Pepe A, Traettino M, Muto M, Cappabianca S, Muto P. Management of painful bone metastases: our experience according to scientific evidence on palliative radiotherapy. Anticancer Res. 2014 Feb;34(2):1011-4.

    PubMed 24511047

  • Falivene S, Pezzulla D, Di Franco R, Giugliano FM, Esposito E, Scoglio C, Amato B, Borzillo V, D'Aiuto M, Muto P. Painful bone metastasis in elderly treated with radiation therapy: Single- or multiple-fraction regimen? A multicentre retrospective observational analysis. Aging Clin Exp Res. 2017 Feb;29(Suppl 1):143-147. doi: 10.1007/s40520-016-0671-x. Epub 2016 Nov 14.

    PubMed 27844454

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Disease, run by National Cancer Institute, Naples at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retrospective Study: Occurrence of palliative radiotherapy treatments in the Campania region (time frame: 20 months (Interval from January 2019 to August 2020)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04595032, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in